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FDA 510(k)

IceSense 3, ProSense, MultiSense

K-Number: K183213 · 2019-12-20

ApplicantIceCure Medical , Ltd.
Decision Date2019-12-20
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IceSense 3, ProSense, MultiSense is the device name listed in this FDA 510(k) record. The listed applicant is IceCure Medical , Ltd.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K183213. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IceSense 3, ProSense, MultiSense?

IceSense 3, ProSense, MultiSense is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is IceCure Medical , Ltd.. The 510(k) number is K183213.

When did IceSense 3, ProSense, MultiSense receive FDA 510(k) clearance?

IceSense 3, ProSense, MultiSense received FDA 510(k) clearance on 2019-12-20, under 510(k) number K183213.

Who is the listed applicant for IceSense 3, ProSense, MultiSense?

The FDA 510(k) record lists IceCure Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IceSense 3, ProSense, MultiSense?

The FDA product code for IceSense 3, ProSense, MultiSense is GEH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02200705Cryoablation of Low Risk Small Breast Cancer- ICE3 TrialCOMPLETEDNCT07629206Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)NOT_YET_RECRUITING

Other records listing IceCure Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260377XSense Cryoablation System with CryoProbesK240892XSense Cryoablation System with Cryoprobes

Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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